Product Tracing in the USA

Recommendation

17-19 September 2024

Granulation & Tableting - Live Online Training
GMP Compliance and Technology for the Manufacture of Oral Solid Dosage Forms

With the Drug Supply Chain Security Act (DSCSA) and the related implementation plan over a ten year period  dated from 2013 new requirements were defined in the USA which are to improve the traceability of prescription drugs within the supply chain.

With the inclusion in the Federal Food, Drug and Cosmetic Act under Section 582 the FDA is authorised to implement a system in the USA which is to guarantee the traceability of drugs in the USA. This concerns manufacturers, wholesale distributors, and repackagers of certain prescription drugs. According to the time plan the requirements for generating, providing and archiving (6 years) of product-tracing information (transaction information (TI), transaction history (TH) and transaction statements (TS)) were scheduled to go into effect on January 1, 2015. An FDA Guideline that was released already in December 2014 has postponed the start. From a mere technical point of view January 1, 2015 remains the date of entry into force. However, the FDA states that it does not intend to take action against companies who do not comply with the DSCSA prior to May 1, 2015. This equals a postponement of four months. The reason for this deferment might be the fear that there could be drug shortages in the USA because of the companies not being able to comply with the new requirements. But the date for the next step, the start for the introduction of serialisation still remains 2017.